JP2010530055A - Lumen polyp detection - Google Patents

Abstract

  In some embodiments of the present invention, an apparatus is provided that includes a capsule 50 that is configured to be swallowed by the subject 54 and pass through the gastrointestinal tract 72 of the subject 54. The capsule 50 is configured to be parallel to the capsule housing 61, at least one radiation source 60 configured to emit radiation, and to rotate relative to the housing 61 and to be emitted by the radiation source 60. Rotating collimator 63 and at least one photon detector 62 configured to detect photons generated in response to the emitted radiation. The apparatus includes a control unit 52 configured to analyze data relating to photons to generate useful information for identifying clinical features of the gastrointestinal tract 72 of the subject 54. Additional embodiments are also described.

Description

Detailed Description of the Invention

[Cross-reference of related applications]
This patent application is an application assigned to the assignee of the present application and is a benefit of Kimchy et al., US Provisional Application No. 60 / 899,640 filed Feb. 6, 2007, “Capsule for collective cancer screening”. , Which is incorporated herein by reference.
[Technical field]
The present invention relates generally to the field of detecting the condition of a body lumen, and specifically to a swallowing device that travels through the large intestine and detects anatomical (body structure) abnormalities.
[background]
Colorectal cancer is one of the leading causes of death in Western countries. Clinical evidence suggests that early detection of primary colorectal cancer results in a 5-year survival rate of over 90%. On the other hand, when a disease in which metastasis has already occurred is detected, a poor prognosis is observed (the course or prospect is not good), and the 5-year survival rate is less than 50% and the recurrence rate is 30%. Suggested by clinical evidence. Colorectal cancer screening tests and early detection have a substantially positive impact on the prognosis of such malignancies.

  Kimchy's PCT Publication No. WO 05/058129 (“No. 129”) (incorporated herein by reference) describes capsules suitable for swallowing by a subject. . The capsule includes (a) at least one radiation source. The at least one radiation source is adapted to emit radiation having an energy of at least 10 keV. The capsule also includes (b) at least one photon detector. At least one photon detector is suitable for detecting photons generated in response to the emitted radiation. The photon has an energy of at least 10 keV. In addition, the device includes a control unit. The control unit is suitable for analyzing data relating to photons to generate useful information for identifying clinically-relevant features of the subject's gastrointestinal (GI) tract.

The following references (both of which are incorporated herein by reference) may be worthy of attention.
US Pat. No. 6,240,312 to Alfano et al. US Pat. No. 5,422,926 to Smith et al. US Pat. No. 5,003,980 to Loo et al. US Pat. No. 4,217,045 to Ziskind Front et al. US Pat. No. 6,567,687 Front US Pat. No. 6,173,201 Trebes et al. US Pat. Nos. 6,134,300 and 6,353,658 Shanks US Pat. No. 5,721,462 Kimchi et al. US Patent Application Publication No. 2002/0099310 Nagler et al. US Patent Application Publication No. 2007/0156047 Kimchy et al. US Patent Application Publication No. 2006/0237652 Zilberstein et al. US Patent Application Publication No. 2005. / 0266074 Rousso US Patent Application Publication No. 2005/0205792 Kimchi et al. US Patent Application Publication No. 2004/0054278 Kimchy et al. US Patent Application Publication No. 2004/0054248 Kimky et al. US Patent Application Publication No. 2004/0015075. Kimchi et al. US Patent Application Publication No. 2003/0139661 Front et al. US Patent Application Publication No. 2001/0041835 Front et al. US Pat. No. 6,368,331 Popper US Patent Application Publication No. 2006/0033029. US Patent Application Publication No. 2005/0055174 to David et al. US Patent Application Publication No. 2004/0204646 to Nagler et al. PCT Publication No. WO 05/112 to Zilberstein et al. No. 895 Nagler et al. PCT Publication No. WO 05/104939 Rousso et al. PCT Publication No. WO 05/067383 Kimchy et al. PCT Publication No. WO 04/042546 Kimchi et al. PCT Publication No. WO 02/16965. Front et al. PCT Publication No. WO 01/62134 Front et al. PCT Publication No. WO 00/49958 Kimchy PCT Publication No. WO 05588129 A Kimkimy PCT Publication No. WO 02/058531 Brochard J et al., “ Estimation of movement parameters of 3D textured surfaces using the autocorrelation function, “Pa tern Recognition Letters 24 (12): 2031-2045 (2003)
Camilleri M et al., “Human gastric emptying and colonic filling of solids, charized by a new method,” Am J Physiol 257 (2 Pt 1): 9084G2
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Madsen JL et al., “Gastrointestinal transit of technology-99m-labeled cellulos fiber and indium-111-1 labeled plastic particles,” J Nucl Med 30 (3): 198: 3.
Pais, Abraham, "Subtle is the Lord ...": Albert Einstein's Science and Life, Oxford (1982)
Proano M et al., “Transit of solids through the human colon: regional qualification in the unprepared bowel,” Am J Physiol 258 (6 Ptl): -G862 (90).
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“X-ray contrast medium,” Medcyclopadia ^™ (www.medcyclopadia.com), from Medical Imaging Encyclopedia Volume 1, the following US patents, both of which are incorporated herein by reference: Can be deserved.

No. 4,689,621, No. 4,726,381, No. 4,763,658, No. 4,765,339, No. 4,774,955, No. 4,803,992, No. 4 , 844,076, 4,883,063, 5,353,807, 5,372,133, 5,395,366, 5,415,181, 5,604 No. 5,531, No. 5,778,882, No. 5,792,053, No. 5,800,350, No. 5,829,437, No. 5,833,603, No. 5,842,977 No. 5,853,005, No. 5,993,378, No. 6,169,914, No. 6,240,312, No. 6,254,548, No. 6,317,927, 6,324,418, 6,343,227, 6,368,27 No. 6,400,974, No. 6,423,056, No. 6,428,469, No. 6,428,531, No. 6,440,069, No. 6,453,199, 6,582,365, 6,584,348, 6,607,301, 6,629,776, 6,632,175, 6,709,387, 719,684, 6,764,440, 6,776,165 [Overview]
Embodiments of the present invention are directed to the detection of polyps and other clinical features that can potentially harbor cancer of the gastrointestinal (GI) tract, particularly colorectal cancer.

  In some embodiments, the subject undergoes colorectal cancer screening treatment. As an example, the subject swallows a radiopaque contrast agent (such as barium sulfate or iodine contrast agent). Subsequently, as an example, after waiting for a predetermined period, the subject swallows the capsule. The capsule comprises a gamma ray, X-ray or beta ray radiation source and a radiation detector. As the capsule travels through the gastrointestinal tract, the radiation source “irradiates” the vicinity of the capsule. The GI contents (including contrast agent), the GI wall, and the tissue outside the GI tract act as a scattering medium for the emitted radiation. As an example, mainly through the Compton scattering process. Scattered photons are retrograde through the GI contents containing the radiopaque contrast agent. In some embodiments, the radiation detector in the capsule also includes fluorescent X-ray (XRF) photons emitted from radiopaque contrast agents, backscattered beta electrons, and / or electrons generated as a result of radiation emission. Is also detected. Count rate information regarding Compton backscattered photons, XRF photons, and / or electrons is transmitted, as an example, to an external recording unit worn by the subject.

  The count rate collected per unit time by each detector is analyzed. These data are presented to the physician in a manner (such as compositional images) that makes it possible to assess the potential for polyps or some other anatomical (body structure) deformation in the gastrointestinal tract. In some embodiments, the data is also analyzed to show the overall (various) areas of the large intestine where such deformations may exist. These polyps or anatomical abnormalities may be the result of the tumor starting to grow in the gastrointestinal tract. In some embodiments, the device allows a physician to: a) tubular and villous polyps, b) neoplastic polyps, and / or polyps with stems and polyps without stems Can be distinguished from each other. Based on the presented data, if the physician suspects the presence of a polyp or some other anatomical abnormality that may be cancerous or a pre-stage of cancer, It is sent to further diagnostic tests such as endoscopy.

Thus, an apparatus provided in accordance with an embodiment of the present invention is
A capsule housing;
At least one radiation source configured to emit radiation;
A rotating collimator configured to rotate relative to the housing and to collimate radiation emitted by the radiation source;
At least one photon detector configured to detect photons generated in response to the emitted radiation;
A capsule configured to be swallowed by the subject and pass through the subject's GI tract;
A control unit configured to analyze data relating to photons to generate useful information for identifying clinical characteristics of the subject's gastrointestinal tract;
It is the apparatus containing.

  In one embodiment, the control unit detects that the capsule has reached the clinical region of interest in the gastrointestinal tract and initiates rotation of the collimator in response to detecting that the capsule has reached the clinical region of interest. Configured as follows.

In certain embodiments, the collimator is rotatable with respect to the housing at an angle of at least 270 degrees.
In some embodiments, the collimator comprises two or more rotary collimators, each collimator being rotatable within an angle of less than 360 degrees with respect to the housing.

In certain embodiments, the photon detector is configured to rotate relative to the housing to detect photons generated in response to the emitted radiation.
In certain embodiments, the detector is rotatable to make an angle of at least 270 degrees.

In some embodiments, the detector has two or more rotary detectors, each detector being rotatable with respect to the housing within an angle of less than 360 degrees.
In addition, an apparatus provided according to an embodiment of the present invention includes:
A capsule configured to be swallowed by the subject, emitting radiation and correspondingly detecting a first signal and a second signal in the gastrointestinal tract of the subject;
Processing the first signal and generating a first image of the gastrointestinal tract in a region where the first signal is detected;
Processing the second signal to generate a second image of the gastrointestinal tract in the region where the second signal was detected;
A control unit configured to detect movement of the capsule by comparing the first image and the second image;
It is the apparatus containing.

Furthermore, an apparatus provided according to an embodiment of the present invention comprises:
At least one beta radiation source;
At least one photon detector configured to detect photons generated in response to radiation emitted from the beta radiation source;
A capsule configured to be swallowed by a subject;
A control unit configured to derive an indication of tissue density near the capsule by analyzing data relating to detected photons;
It is the apparatus containing.

In certain embodiments, the control unit is configured to distinguish between a) tubular and villi polyps and b) neoplastic polyps as a function of tissue density readings.
In certain embodiments, the apparatus further comprises at least one electron detector configured to detect electrons generated in response to radiation emitted from the beta radiation source, and the control unit relates to the detected photons. By analyzing the data and data relating to the detected electrons, an indication of tissue density in the vicinity of the capsule is derived.

In addition, an apparatus provided according to an embodiment of the present invention includes:
At least one beta radiation source;
At least one electron detector configured to detect electrons generated in response to radiation emitted from the beta radiation source;
A capsule configured to be swallowed by a subject;
A control unit configured to derive an indication of tissue density near the capsule by analyzing data relating to detected electrons;
It is the apparatus containing.

In certain embodiments, the control unit is configured to distinguish between a) tubular and villi polyps and b) neoplastic polyps as a function of tissue density readings.
Furthermore, an apparatus provided according to an embodiment of the present invention comprises:
At least one radiation source configured to emit radiation;
At least one photon detector configured to detect Compton backscattered photons generated in response to radiation emitted by the radiation source;
A capsule configured to be swallowed by a subject;
Configure to distinguish between a) tubular and villi polyps and b) neoplastic polyps by analyzing data on detected Compton backscattered photons and deriving an indication of tissue density near the capsule A control unit,
It is the apparatus containing.

In certain embodiments, the radiation source is configured to emit one or more radioactive particles selected from the group consisting of x-ray photons, gamma photons, and beta electrons.
Furthermore, an apparatus provided according to an embodiment of the present invention comprises:
At least one radiation source configured to emit radiation;
At least one photon detector configured to detect Compton backscattered photons and XRF photons generated in response to radiation emitted by the radiation source;
A capsule configured to be swallowed by a subject;
Distinguish between a) tubular and villous polyps and b) neoplastic polyps by analyzing data on detected Compton backscattered and XRF photons and deriving an indication of tissue density near the capsule A control unit configured as
It is the apparatus containing.

In certain embodiments, the radiation source is configured to emit one or more radioactive particles selected from the group consisting of x-ray photons, gamma photons, and beta electrons.
In addition, an apparatus provided according to an embodiment of the present invention includes:
At least one radiation source configured to emit radiation;
At least one detector configured to detect electrons generated in response to radiation emitted by the radiation source;
A capsule configured to be swallowed by a subject;
It is configured to distinguish between a) tubular and villous polyps and b) neoplastic polyps by analyzing data on detected beta radiation and deriving an indication of tissue density near the capsule A control unit;
It is the apparatus containing.

In certain embodiments, the radiation source is configured to emit one or more radioactive particles selected from the group consisting of x-ray photons, gamma photons, and beta electrons.
Furthermore, an apparatus provided according to an embodiment of the present invention comprises:
At least one radiation source configured to emit radiation;
At least one detector configured to detect radiation electrons emitted by the radiation source and photons generated in response thereto;
A capsule configured to be swallowed by a subject;
A control unit that distinguishes between a) tubular and villous polyps and b) neoplastic polyps by analyzing data on detected beta radiation and deriving an indication of tissue density near the capsule;
It is the apparatus containing.

In addition, an apparatus provided according to an embodiment of the present invention includes:
A radiation source;
A rotating shield configured to cover the radiation source when not rotating and configured to expose the radiation source when rotating at a rotational speed exceeding a threshold;
A capsule configured to be swallowed by a subject;
A control unit configured to rotate the shield at a rotational speed exceeding a threshold;
It is the apparatus containing.

In some embodiments, the rotary shield is configured to expose the radiation source by centrifugal force generated by rotation of the shield.
Furthermore, an apparatus provided according to an embodiment of the present invention comprises:
A first antenna configured to radiate a first RF pulse and a second RF pulse, respectively, at a first time and a second time while the capsule is in the gastrointestinal tract;
A second antenna configured to detect each RF pulse;
A capsule configured to be swallowed by the subject and travel through the subject's gastrointestinal tract;
A control unit configured to identify movement of the capsule through the gastrointestinal tract in response to changes in the detected first and second RF pulses;
It is the apparatus containing.

In addition, an apparatus provided according to an embodiment of the present invention includes:
While the capsule is in the gastrointestinal tract, it has two electrodes configured to cause a voltage drop between a first time and a second time, and is swallowed by the subject to travel through the subject's gastrointestinal tract A capsule composed of
An apparatus comprising a control unit configured to identify movement of a capsule through the gastrointestinal tract in response to changes in current flowing between electrodes at a first time and a second time.

Furthermore, an apparatus provided according to an embodiment of the present invention comprises:
A capsule having a sensor configured to detect the placement of the capsule and configured to be swallowed by the subject to travel through the subject's gastrointestinal tract;
A control unit configured to determine that the capsule has been expelled from the subject's anus, depending on the detected arrangement;
It is the apparatus containing.

  In certain embodiments, the capsule is configured to acquire data regarding the gastrointestinal tract while traveling through the gastrointestinal tract, and the control unit is detected in response to detecting that the capsule has been expelled from the subject's anus. Configured to download data from the capsule.

In addition, an apparatus provided according to an embodiment of the present invention includes:
At least one radiation source;
At least one photon detector configured to detect photons generated in response to radiation emitted from the radiation source;
A capsule configured to be swallowed by the subject and pass through the subject's gastrointestinal tract;
A control unit configured to distinguish between polyps with stalks and polyps without stalks in the gastrointestinal tract of the subject by analyzing data on detected photons;
It is the apparatus containing.

In certain embodiments, the radiation source comprises a beta radiation source.
Furthermore, an apparatus provided according to an embodiment of the present invention comprises:
At least one radiation source configured to emit radiation;
At least one photon detector configured to detect Compton backscattered photons and XRF photons generated in response to radiation emitted by the radiation source;
A capsule configured to be swallowed by the subject and pass through the subject's large intestine;
(A) Analyzing the Compton photon flux and XRF photon flux of photons detected at a plurality of dense points along the large intestine, and (b) determining the low degree of change in contrast agent concentration at the dense points in the large intestine of the subject. A control unit configured to predict the distance between the capsule and the colon wall by guessing;
It is the apparatus containing.

In addition, methods provided according to embodiments of the present invention include:
Administering a contrast agent to the subject;
Administering a capsule to a subject, wherein the capsule is configured to be swallowed by the subject to advance through the subject's large intestine;
Emitting radiation from the capsule through a contrast agent in the subject's large intestine;
Detecting a photon bundle of Compton backscattered photons and XRF photons generated in response to radiation emitted at a plurality of dense points along the large intestine;
Determining the distance between the capsule and the colon wall by analyzing the detected Compton and XRF photon flux and inferring a low degree of contrast change in the concentration of the contrast agent in the subject's colon. ,
It is a method including.

In some embodiments, determining the distance includes determining an average contrast agent concentration based on the bundle detected at the dense point.
In certain embodiments, detecting the photon flux includes detecting the photon flux at each time the capsule is at a plurality of confluences, wherein the confluence is within a single bulge of the large intestine.

  In some embodiments, detecting the photon flux includes detecting the photon flux at each of the capsules at a plurality of dense points, wherein the dense point is within a range of 20 mm to 40 mm in length of the large intestine. It is in.

  The present invention can be more fully understood from the detailed description of the embodiments based on the following drawings.

1 is a schematic diagram of a screening system according to an embodiment of the present invention. 1 is a schematic representation of a capsule according to an embodiment of the present invention. 1 is a schematic illustration of a capsule with shield vanes according to an embodiment of the present invention. 1 is a schematic illustration of a capsule with shield vanes according to an embodiment of the present invention. A height map of each of a polyp with a flat polyp and a stem, both polyps being induced in the large intestine of a pig, the map being generated according to an embodiment of the present invention. A height map of each of a polyp with a flat polyp and a stem, both polyps being induced in the large intestine of a pig, the map being generated according to an embodiment of the present invention.

[Detailed Description of Embodiment]
With reference to FIG. FIG. 1 is a schematic diagram of a screening system 40 for screening a GI tract 72 of a subject 54 according to an embodiment of the present invention. The system 40 is in many aspects generally similar to the screening system described in publication 129. As an example, the system 40 includes an ingestible capsule 50 and an external data recording unit 52. In one application, the data recording unit 52 is mounted on a belt 59 around the subject's waist (see FIG. 1) or anywhere on the subject's body, such as a wrist (configuration not shown). Alternatively, in some applications, the capsule 50 includes an internal data recording unit and no external data recording unit 52 is provided. In these applications, the data recorded by the capsule 50 is read after the capsule is ejected from the body. In one example screening procedure using system 40, oral contrast agent 70 is administered to the subject. As an example, the contrast agent 70 is adapted to pass through the gastrointestinal tract and be excreted along with the feces without being substantially absorbed into the bloodstream. After contrast medium administration (for example, several hours after contrast medium administration), the subject 54 swallows the capsule 50.

  With reference to FIG. FIG. 2 is a schematic diagram of a capsule 50 according to an embodiment of the present invention. The capsule 50 comprises at least one radiation source 60. The radiation source 60 is adapted to emit gamma and / or X-rays (ie, radiation having an energy of at least 10 keV). The radiation source is disposed in the housing 61. Alternatively or additionally, the radiation source 60 and / or the additional radiation source disposed within the capsule emits beta radiation. The capsule 50 further comprises at least one gamma and / or x-ray radiation detector 62. It further typically comprises (in one example) at least one collimator 63 that is adapted to collimate the radiation emitted by the radiation source 60. Alternatively or additionally, detector 62 and / or additional detectors disposed within the capsule detect backscattered beta particles and / or electrons generated in response to radiation emitted from radiation source 60. It is so fit. For certain applications, the radiation source 60 comprises a radioisotope. Alternatively, the radiation source 60 comprises a miniature radiation generator. The capsule 50 includes, as an example, an electronic circuit 64, a power supply device 66 (for example, a battery), a wireless communication device for communicating with the external data recording unit 52, and a radiation shield 68. In some embodiments, the capsule includes a pressure sensor 69. In various preferred applications, the wireless communication device may comprise electronic devices 65 and 67. Electronic devices 65 and 67 may include antennas or electrodes.

  In one example, the shield 68 is configured to shield (protect) the subject from emitted radiation when the capsule is not scanning the gastrointestinal tract. In embodiments where beta radiation is emitted from the capsule, the shield comprises, by way of example, a high density ceramic material that blocks electrons and at the same time secondary “stopping radiation” x-rays (secondary “stopping radiation” x-rays. ) Is reduced. In addition, a combination of a ceramic shield and a high atomic number metal shield on its outer periphery may be used to reduce secondary x-ray emission. Secondary X-rays result from the Compton interaction of photons that exit the radiation source 60 through the collimator holes 63 and impinge on the capsule housing. Some of the photons from the Compton interaction on the surface can return to the detector 62 and be detected. In some embodiments, the shield 68 reduces the number of photons that reach the detector after this interaction.

  In some embodiments of the present invention, radiation source 60, collimator 63, radiation shield 68, radiation detector 62, and / or electronic circuit 64 rotate during scanning. For example, the collimator and / or detector can rotate beyond 270 degrees, for example, up to 360 degrees.

  In some embodiments, as the pressure sensor 69 senses a change in pressure associated with the contraction of the large intestine, the capsule scans by opening the collimator 63 and exposing the radiation source 60. To start. Subsequently, the radiation shield 68 and the radiation detector 62 start rotating at a speed of 2 to 50 times per second in one example. In some applications, rotation starts at a rate of 50 to 500 times per second. As each collimator 63 allows (allows) the emission of gamma or X-ray photons to a particular angular region, the radiation detector 62 that rotates with the collimator includes Compton backscattered photons, fluorescent X-ray photons, and Detect electrons. Compton backscattered photons, fluorescent X-ray photons, and / or electrons return from the colon contents within the angular region. In some embodiments, the rotating portion of the capsule rotates, allowing the entire circumference of the capsule to be scanned as the capsule moves forward as a result of movement of the colon contents due to the contraction of the colon wall. In some embodiments, the radial scanning resolution of the capsule can be changed by changing the rotational speed of the rotatable portion of the capsule and / or by changing the time interval over which the photon flux is combined for each angular region. fluctuate. For example, if the photon flux is combined over a longer period in each angular region, each angular region will be larger and there will be fewer angular regions per rotation of the capsule.

  For certain applications, the capsule comprises a plurality of detectors. Each detector rotates to an angle of less than 360 degrees. However, multiple detectors scan 360 degrees. For example, the capsule may comprise two detectors, each rotating up to 180 degrees. The combination of the two detectors allows a 360 degree scan. Alternatively or additionally, the capsule comprises a plurality of collimators 63. Each collimator rotates to an angle of less than 360 degrees. However, the multiple collimators scan 360 degrees. For example, the capsule may comprise two collimators, each rotating up to 180 degrees. The combination of the two collimators may allow the radiation source 60 to be exposed to 360 degrees around the large intestine.

  For some applications, as described above, one part of the capsule rotates while the other part of the capsule is generally immobile. For example, the immobile portion may include a motor (not shown), a power supply device (eg, battery 66), a pressure sensor 69, and / or a tilt sensor (not shown). In certain applications, the transmission of signals and the supply of current from the stationary part of the capsule to the rotating part of the capsule are performed via slip rings. The slip ring is configured to transmit a data signal and supply a current. In some embodiments, the rotary encoder is incorporated within the capsule. As the rotary encoder rotates, the rotational position of the rotating portion of the capsule can be tracked by the electronic circuit and the capsule software. This allows the circuit to associate each detected photon with its appropriate angular region. In some applications, the rotary encoder is built into the slip ring via a non-continuous conductive surface on the slip ring that is divided into equal areas (in the example, 4 to 128 areas). The position of the rotary slip ring can be detected by the electronic circuit in accordance with the rotation of the rotary slip ring. In some embodiments, in order to mark the completion of the 360 degree rotation, the encoder includes a marker such as a missing area location. For example, this allows the electronics to resynchronize with each rotation, thus compensating for variations in rotational speed or position detection errors.

  For some applications, the capsule 50 scans the large intestine at predetermined time intervals. This can ensure scanning of the entire large intestine even when the capsule is moving very slowly and no pressure change is detected. For example, the capsule may scan the large intestine every 5-30 seconds and / or every 0.5-5 minutes.

  In one application, the radiation shield 68 is set to open the collimator 63 only when the capsule senses movement of the capsule itself, eg, in response to detection of a pressure change in the large intestine by the pressure sensor 69. . Thus, scanning the large intestine and exposing the patient to radiation is generally limited only to the period during which the large intestine contents are moving. Thus, the patient is generally less exposed to radiation. In some embodiments, this saves power consumption because the scan is only performed when the capsule senses a pressure change.

  In some embodiments, in response to the capsule 50 detecting a pressure change indicative of defecation, the capsule continuously scans as fast movement through the large intestine is expected. In one example, in response to sensing a pressure change, the capsule continuously scans for a period of 10 seconds to 1 minute, or 1 minute to 10 minutes. In some embodiments, capsule movement is detected using other sensing means.

  In some embodiments, radio (RF) transmission and reception are used to measure whether the capsule 50 is moving and / or to detect the speed of movement of the capsule. For this purpose, the capsule transmits a radio short wave (RF pulse) from the electronic device 65 (for example, an antenna) every few seconds, for example, every 1 to 60 seconds. A signal is then received from an electronic device 67 (eg, another antenna) located at a different location on the capsule. If the capsule moves in the last time interval, the received signal will have a different amplitude. Due to the low impedance and high attenuation of the colon contents, any change in the relative position of the capsule in the colon will change the RF signal.

  In some embodiments, low voltage pulse transmission and reception are used to measure whether the capsule 50 is moving and / or to detect the speed of movement of the capsule. For this purpose, the capsule causes a low frequency voltage pulse to be applied between two or more electronic devices 65, 67 (eg, electrodes) located at different locations on the capsule every few seconds, for example every 1-60 seconds. generate. If the capsule moves in the last time interval, the current induced by the voltage pulse will have a different amplitude due to the impedance change caused by the change in the relative position of the capsule in the large intestine.

  In some embodiments, a magnetic flow meter well known in the art is used to measure the moving speed of the capsule 50. In one example, a small magnet is placed in close proximity to the capsule 50 or on the surface of the capsule 50 and a magnetic field is applied across the large intestine. Two or more electrodes measure the voltage induced by the movement of the magnet across the applied magnetic field. The speed of capsule movement is inferred from the strength of the induced voltage.

  In some embodiments, the capsule 50 and / or the external data recording unit 52 activates an adaptation algorithm to optimize the frequency of scanning. The algorithm works by evaluating the difference in the measured values of the entire colon imaging area as a function of time. In certain embodiments, the algorithm maintains and passes a record of a given number of scan measurements (eg, the Compton backscattered photon count rate for each of a given number of scan measurements) for each region. Calculate the average for those regions. The algorithm then compares the current measurement with the average value. If the difference between the mean squared value and the current measured value squared is below the lower threshold, the next measurement is set to be made following a time interval longer than the previous time interval. . In one example, the time interval is not extended beyond the maximum time interval. If the difference between the mean square and the current measured square is above the upper threshold, the next measurement is made following a time interval that is shorter than the previous time interval. If the difference between the mean square and the current measured square is between the upper and lower thresholds, the time interval remains constant until the next measurement is taken.

  In some embodiments, the fitting algorithm evaluates pressure measurement differences as a function of time. For example, the algorithm may keep a record of several past pressure measurements and may calculate the average and standard deviation of these past time pressure measurements. The algorithm then compares the current pressure measurement with the average value. If the difference between the mean square and the new measured square is greater than a certain threshold, the capsule starts scanning or scans at a higher speed than previously scanned. In some embodiments, the threshold is set in accordance with an average of several past measurements and a standard deviation of these measurements. In one example, the capsule starts scanning in response to detecting pressure. The pressure is 1 to 10 standard deviations or a given value +1 to 10 standard deviations. Their standard deviation is above the average of the previous measurements (there are a given number).

  In some embodiments, each image is generated in response to data detected by radiation detector 62. An adaptation algorithm is used and the movement and / or movement speed of the capsule is detected by comparing the respective images with each other. In some embodiments, the adaptation algorithm is applied in response to the capsule detecting a pressure change. In one example, the algorithm varies the time interval between successive scans of the capsule in response to detection of capsule movement and / or speed of movement. In some embodiments, the algorithm builds an image that is the average of the previous several images, and then the algorithm compares the current image with the average image. In one example, the algorithm varies the time interval between successive scans of the capsule in response to detection of capsule movement and / or speed of movement. In some embodiments, the algorithm is activated in response to detecting a pressure change by the pressure sensor.

  In an embodiment of the invention, a tilt sensor is employed in the stationary part of the capsule and the 3D tilt angle of the capsule is monitored. The 3D tilt angle is an angle relative to the center of gravity of the earth. In order to readjust the reference system during post processing, that information is used by the capsule to sense rotation during scanning. In one example, this information is transmitted from the capsule to the external data recording unit 52.

  In some embodiments, data relating to the tilt angle of the capsule, data relating to capsule pressure changes, and / or data relating to capsule acceleration are used to identify when the capsule is expelled from the subject's anus. In one example, in response to detecting that the capsule has been ejected, the data from the capsule is immediately transmitted to the external data recording unit 52.

  In some embodiments, the radiation source 60 emits beta radiation. The emitted high energy electrons interact directly with the contents of the large intestine, the tissues of the large intestine wall, and the tissues outside the large intestine. The electrons are scattered by these interactions, and some of the electrons are backscattered at various energy levels and detected by the detector 62. The emitted electrons, in one example, have an energy exceeding 1 megaelectron volt (MeV), for example, 1.5-7 MeV. For example, radiation based primarily on beta radiation may use less radiation than gamma and / or x-ray radiation. This is because electrons interact with matter with a higher probability than photons. Furthermore, beta radiation has a maximum range that depends on the energy of the electrons. For example, the electrons emitted by Y-90 have a maximum range of 11 mm in water. Therefore, exposure to radiation is limited. Specifically, it is limited so that tissues outside the large intestine are limitedly exposed or not exposed to radiation.

  In some applications, electron backscattering is used to detect small changes in tissue density near the capsule 50. This is also used to distinguish between a) tubular and villous polyps and b) neoplastic polyps. Tubular and villous polyps, in one example, have a higher density than neoplastic polyps. Tubular and villous polyps are more likely to be cancerous than neoplastic polyps. In some embodiments, the emitted beta radiation generates electrons and / or XRF photons in the large intestine.

  In some embodiments of the invention, electrons and / or photons generated in response to beta radiation are detected and used to quantify the density of tissue proximate to the capsule. This information can be useful for physicians to classify polyps as either a) tubular or villous, or b) neoplastic.

  In some embodiments, the radiation source 60 emits beta radiation as well as gamma and / or x-ray radiation. For example, beta radiation may be used for sensitive detection in the proximity of the capsule. On the other hand, gamma and / or X-ray radiation may be more sensitive (may react better) in the longer range from the capsule. In such embodiments, detector 62 detects backscattered electrons, and backscattered Compton and XRF photons, by way of example. In some embodiments, the capsule has a first radiation source that emits photons and an additional radiation source that emits beta radiation. In some embodiments, the capsule has a first radiation detector that detects photons and an additional detector that detects beta radiation.

  In some embodiments of the present invention, Compton backscatter that occurs in response to emitted X-rays and / or gamma photons is used to quantify the density of tissue proximate to the capsule. This information can be useful for physicians to classify polyps as either a) tubular or villous, or b) neoplastic.

  In some embodiments of the invention, Compton backscatter and XRF photons generated in response to emitted X-rays and / or gamma photons are used to quantify the density of tissue proximate to the capsule. As an example, this is accomplished by associating XRF photon flux variations with Compton backscattered photon flux variations, as described in the following paragraphs. Compton backscattered photon flux variations that are not associated with corresponding fluorescent X-ray photon flux variations are taken to indicate changes in tissue density. This may be used to classify polyps as a) tubular or villous, or b) neoplastic.

  In response to the radiation emitted by radiation source 60, XRF photons are emitted only from colon contents containing contrast agent 70, in one example. Compton backscattered photons are emitted from the contents of the large intestine and from the wall of the large intestine and beyond it. Thus, in some embodiments, the XRF photon flux is normalized and then subtracted from the Compton photon flux. Then, it is possible to automatically evaluate the photon flux related to the large intestine and the tissue on the other side. In one example, the Compton photon flux is proportional to the square root of the distance from the capsule to the tissue surface. The difference between the normalized XRF photon flux and the Compton photon flux is mainly due to the colon tissue. In addition, the Compton photon flux depends on the density of the tissue. Thus, by analyzing the Compton photon flux, the automatic algorithm provided by some embodiments of the present invention determines the density of the tissue from which the Compton photons are backscattered.

  Next, FIGS. 3A and 3B will be described. 3A and 3B are schematic views of the radiation shield 68 of the capsule 50 with the shield blades 80 according to an embodiment of the present invention. In an embodiment of the invention, when the capsule is not scanning the gastrointestinal tract, the shield blade is closed (as shown in FIG. 3A) and the subject is shielded (protected) from the radiation source 60. To initiate scanning of the gastrointestinal tract, the radiation source 60 is exposed as the shield 68 rotates with the detector 62. The rotation causes a centrifugal force to act on the shield blade 80, opening the shield blade 80 and exposing the radiation source 60 (as shown in FIG. 3B). When not rotating, the shield blades 80 are held closed by the use of a spring, for example. The rotating shield blades are arranged in the casing 61 of the capsule 50, thereby avoiding contact between the movable part of the capsule and the colon wall. In other embodiments, other techniques are employed to move shield 68 and / or radiation source 60 (eg, by activation of a solenoid).

  Next, FIGS. 4A and 4B will be described. 4A and B are height maps of respective polyps induced in the large intestine of the first and second pigs, respectively. The height map has been generated according to an embodiment of the present invention. In some embodiments of the invention, processing algorithms are employed to distinguish between polyps with stems and polyps without stems. The algorithm relies on the fact that, in one example, the capsule tends to touch a polyp that is larger than a few millimeters (eg, greater than 6 mm). This is because the colon wall contracts in order to push the capsule forward. Upon contact with the polyp, the polyp is aligned along the path of the capsule. Therefore, as the capsule advances in the vicinity of the polyp, the polyp extends along the longitudinal axis of the large intestine. As the capsule passes through the polyp due to elongation of the polyp, the stem of the polyp is exposed to the capsule. In one example, polyp stretching causes asymmetry in the polyp image because the polyp center is dragged in the direction of capsule movement.

FIG. 4A is a height map of a flat polyp induced in the colon of the first pig. The map has been generated using the device described above. FIG. 4B is a polyp height map with stems induced in the colon of a second pig. Differences can be observed in the shape of each height map. The map of FIG. 4B has an elongated tail associated with a polyp with a stem. The direction of movement of the capsule was upward on the page, and the polyp was dragged in that direction. In some embodiments, the likelihood that the polyp is potentially cancerous is assessed by determining whether the polyp has a stem. (In clinical studies on polyps and their progression to cancer, those with stems are unlikely to become cancerous, while polyps without stems (flat polyps) can become cancerous It is suggested that the nature is high.)
In some embodiments of the invention, the distance between the capsule and the colon wall at a given point is predicted. In addition, the size of the polyp or other structure within the large intestine is expected. To enable these predictions, the XRF bundle and the Compton backscattered photon bundle are measured simultaneously in multiple measurements throughout the large intestine, and these values are recorded for post processing. In one example, the concentration of contrast agent varies along the large intestine. Furthermore, both XRF and Compton photon fluxes vary in relation to contrast agent concentration. Thus, by detecting XRF and Compton backscatter data along the large intestine, it is possible to predict the actual distance between the capsule and the large intestine wall and the actual size of features in the large intestine. This is done by simultaneously solving the equations related to the XRF and Compton photon flux related to the two unknowns, distance and contrast agent concentration.

For X-ray fluorescence (XRF), the equation describing the distance between the capsule and the colon wall is as a function of the detected photon flux:
Lxrf = Kxrf * [Ln (Ixrf) / (− μxrf * ρ)]
Where Lxrf is the predicted distance between the capsule and the colon wall. Kxrf is a known scalar constant. Ixrf is the measured XRF photon flux. μxrf is a known XRF interaction probability. ρ is the contrast agent concentration.

For Compton backscattering (COMP), the equation describing the distance between the capsule and the colon wall is as a function of the detected photon flux:
Lcomp = Kcomp * (Ln (1-Icomp) / − μcomp * ρ)
Where Lcomp is the predicted distance between the capsule and the colon wall. Kcomp is a known scalar constant. Icomp is the measured Compton photon flux. μcomp is the known Compton interaction probability. ρ is the contrast agent concentration.

  Since these two predicted values represent the same true distance at any point along the large intestine, the two equations can be solved simultaneously. This is because there are only two unknowns, namely the true distance L between the capsule and the colon wall and the contrast agent concentration (ρ).

L = Kxrf * [(Ln (Ixrf) / (− μxrf * ρ)]
(Equation 1)
L = Kcomp * [Ln (1-Icomp) / (− μcomp * ρ)]
(Equation 2)
The large intestine is divided into regions called bulges. In one example, within each bulge, the contrast agent concentration remains approximately constant. In one example, the concentration of the contrast agent varies between adjacent bulges. As an example, the length of each bulge is 20 mm to 40 mm. In some embodiments, multiple measurements are made within each bulge to provide an average contrast agent concentration for that bulge. As an example, the simultaneous equations provided above can be derived from a plurality of positions (eg, 2-20 or 20-40 measurements) within a bulge (eg, a position in the 20 mm to 40 mm length segment of the large intestine). The average XRF and Compton photon flux measurements taken from are used to solve for each bulge. Within each bulge, it can be assumed that the contrast agent has not changed substantially, and a simultaneous equation using the average photon flux is solved to provide the average contrast agent concentration for that bulge. As an example, the average contrast agent concentration of the bulge is then used for each individual measurement of the bulge with respect to the contrast agent concentration. Equations 1 and 2 are solved to provide the distance from the colon wall to the capsule.

  In some embodiments, for example, a moving average of 2-20 or 20-40 XRF and Compton photon flux measurements is calculated every 20-40 mm of colon length. For each average of the Compton and XRF photon flux, the standard deviation of the mean is calculated. In one example, the standard deviation of the average photon flux changes as the capsule moves from one bulge to the next. In some embodiments, the algorithm determines a set of average measurements corresponding to measurements taken from within the same bulge by detecting changes in the standard deviation of the moving average measurements. The average contrast agent concentration in the bulge is then determined by solving the simultaneous equations disclosed above for that bulge.

  The scope of the present invention includes the embodiments described in the following applications and is incorporated herein by reference. In certain embodiments, the techniques and apparatus described in one or more of the following applications are combined with the techniques and apparatus described herein.

International Patent Application No. PCT / IL2004 / 001140 “Intra-lumen polyp detection” filed on December 16, 2004, or US Patent Application No. 10 / 596,065, which is a national transition application thereof,
US Provisional Patent Application No. 60 / 531,690 “Intra lumen polyp detection” filed December 17, 2003, and / or US Provisional Patent Application 60 / 559,695 filed March 31, 2004 "Intra-lumen polyp detection"
Those skilled in the art will appreciate that the present invention is not particularly limited to that shown and described above. Rather, the scope of the present invention includes both the various features described above, as well as combinations and subcombinations of features and modifications not found in the prior art, by reading the foregoing description, It will be apparent to those skilled in the art.

Claims (58)

A capsule housing;
At least one radiation source configured to emit radiation;
A rotating collimator configured to rotate relative to the housing and to collimate the radiation emitted by the radiation source;
At least one photon detector configured to detect photons generated in response to the emitted radiation and configured to be swallowed by the subject and pass through the gastrointestinal tract of the subject. Capsules,
A control unit configured to analyze data relating to the photons to generate useful information for identifying clinical characteristics of the gastrointestinal tract of the subject;
A device comprising:   The control unit detects that the capsule has reached the clinical focus area in the gastrointestinal tract, and starts rotating the collimator in response to detecting that the capsule has reached the clinical focus area The apparatus of claim 1, configured to   The apparatus of claim 1, wherein the collimator is rotatable to form an angle of at least 270 degrees with respect to the housing.   The apparatus according to claim 1, wherein the collimator is composed of two or more rotary collimators, and each collimator is rotatable within an angle of less than 360 degrees with respect to the housing.   The apparatus according to claim 1, wherein the photon detector is configured to rotate relative to the housing to detect photons generated in response to the emitted radiation.   The apparatus of claim 5, wherein the detector is rotatable to form an angle of at least 270 degrees.   6. The apparatus of claim 5, wherein the detector comprises two or more rotary detectors, each detector being rotatable within an angle of less than 360 degrees relative to the housing. A capsule configured to be swallowed by a subject, emitting radiation, and correspondingly detecting a first signal and a second signal in the subject's gastrointestinal tract;
Processing the first signal to generate a first image of the gastrointestinal tract in a region where the first signal is detected;
Processing the second signal to generate a second image of the gastrointestinal tract in a region where the second signal is detected;
A control unit configured to detect movement of the capsule by comparing the first image and the second image;
A device comprising: At least one beta radiation source;
At least one photon detector configured to detect photons generated in response to radiation emitted from the beta radiation source;
A capsule configured to be swallowed by a subject;
A control unit configured to derive an indication of tissue density near the capsule by analyzing data relating to the detected photons;
A device comprising:   10. The apparatus of claim 9, wherein the control unit is configured to distinguish between a) tubular and villi polyps and b) neoplastic polyps as a function of the tissue density reading. At least one electron detector configured to detect electrons generated in response to radiation emitted from the beta radiation source;
The control unit is configured to derive an indication of tissue density near the capsule by analyzing data relating to the detected photons and data relating to the detected electrons. The device described. At least one beta radiation source;
At least one electron detector configured to detect electrons generated in response to radiation emitted from the beta radiation source;
A capsule configured to be swallowed by a subject;
A control unit configured to derive an indication of tissue density near the capsule by analyzing data relating to the detected electrons;
A device comprising:   13. The device of claim 12, wherein the control unit is configured to distinguish between a) tubular and villi polyps and b) neoplastic polyps as a function of the tissue density reading. At least one radiation source configured to emit radiation;
At least one photon detector configured to detect Compton backscattered photons generated in response to radiation emitted by the radiation source;
A capsule configured to be swallowed by a subject;
Analyzing data on the detected Compton backscattered photons to derive an indication of tissue density near the capsule to differentiate between a) tubular and villi-like polyps and b) neoplastic polyps A control unit configured with:
A device comprising:   The apparatus of claim 14, wherein the radiation source is configured to emit one or more radioactive particles selected from the group consisting of x-ray photons, gamma photons, and beta electrons. At least one radiation source configured to emit radiation;
At least one photon detector configured to detect Compton backscattered photons and XRF photons generated in response to radiation emitted by the radiation source;
A capsule configured to be swallowed by a subject;
Analyzing data on the detected Compton backscattered photons and XRF photons to derive an indication of tissue density near the capsule, thereby a) tubular and villi-like polyps, and b) neoplastic polyps. A control unit configured to distinguish;
A device comprising:   The apparatus of claim 16, wherein the radiation source is configured to emit one or more radioactive particles selected from the group consisting of x-ray photons, gamma photons, and beta electrons. At least one radiation source configured to emit radiation;
At least one detector configured to detect electrons generated in response to radiation emitted by the radiation source;
A capsule configured to be swallowed by a subject;
Configured to distinguish between a) tubular and villous polyps and b) neoplastic polyps by analyzing data relating to the detected beta radiation and deriving an indication of tissue density near the capsule A control unit,
A device comprising:   The apparatus of claim 18, wherein the radiation source is configured to emit one or more radioactive particles selected from the group consisting of x-ray photons, gamma photons, and beta electrons. At least one radiation source configured to emit radiation;
At least one detector configured to detect electrons and photons generated in response to radiation emitted by the radiation source;
A capsule configured to be swallowed by a subject;
Configured to distinguish between a) tubular and villous polyps and b) neoplastic polyps by analyzing data relating to the detected beta radiation and deriving an indication of tissue density near the capsule A control unit,
A device comprising: A radiation source;
A rotary shield configured to cover the radiation source when non-rotating and configured to expose the radiation source when rotated at a rotational speed exceeding a threshold;
A capsule configured to be swallowed by a subject;
A control unit configured to rotate the shield at a rotational speed exceeding the threshold;
A device comprising:   The apparatus of claim 21, wherein the rotary shield is configured to expose the radiation source by centrifugal force generated by rotation of the shield. A first antenna configured to emit a first RF pulse and a second RF pulse, respectively, at a first time and a second time while the capsule is in the gastrointestinal tract;
A second antenna configured to detect the respective RF pulses;
A capsule configured to be swallowed by the subject and advanced through the subject's gastrointestinal tract;
A control unit configured to identify movement of the capsule through the gastrointestinal tract in response to changes in the detected first and second RF pulses;
A device comprising: While the capsule is in the gastrointestinal tract, it has two electrodes configured to produce a voltage drop between a first time and a second time, and is swallowed by the subject to A capsule configured to travel;
A control unit configured to identify movement of the capsule through the gastrointestinal tract in response to changes in current flowing between the electrodes at the first time and second time;
A device comprising: A capsule having a sensor configured to detect the placement of the capsule and configured to travel through the subject's gastrointestinal tract as swallowed by the subject;
A control unit configured to determine that the capsule has been expelled from the anus of the subject in response to the detected arrangement;
A device comprising: The capsule is configured to acquire data regarding the gastrointestinal tract while traveling through the gastrointestinal tract;
The control unit is configured to download the detected data from the capsule in response to detecting that the capsule has been expelled from the anus of the subject.
26. The device of claim 25. At least one radiation source and at least one photon detector configured to detect photons generated in response to radiation emitted from the radiation source;
A capsule configured to be swallowed by a subject and passed through the subject's gastrointestinal tract;
A control unit configured to distinguish between polyps with stalks and polyps without stalks in the gastrointestinal tract of the subject by analyzing data relating to the detected photons; ,
A device comprising:   28. The apparatus of claim 27, wherein the radiation source comprises a beta radiation source. At least one radiation source configured to emit radiation;
At least one photon detector configured to detect Compton backscattered photons and XRF photons generated in response to radiation emitted by the radiation source;
A capsule configured to be swallowed by the subject and pass through the subject's large intestine;
(A) analyzing the Compton and XRF photon bundles of photons detected at a plurality of dense points along the large intestine;
(B) predicting the distance between the capsule and the large intestine wall by estimating the degree of low concentration change of the contrast agent at the dense point in the large intestine of the subject,
A control unit configured as
A device comprising: Emitting radiation from within the subject's gastrointestinal tract;
Directing the radiation around a portion of the gastrointestinal tract by rotating at least one rotary collimator;
Detecting photons generated in response to the emitted radiation;
Generating useful information for identifying clinical characteristics of the subject's gastrointestinal tract by analyzing data relating to the detected photons;
A method comprising:   The method further comprising: detecting a time point when the collimator reaches a clinical focus area; and starting rotation of the collimator in response to detecting that the collimator reaches the clinical focus area. 30. The method according to 30.   32. The method of claim 30, wherein directing the radiation around the portion of the gastrointestinal tract comprises rotating the collimator to an angle greater than 270 degrees.   31. The method of claim 30, wherein detecting photons generated in response to the emitted radiation comprises rotating a detector to an angle greater than 270 degrees.   32. The method of claim 30, wherein directing the radiation around the portion of the gastrointestinal tract includes rotating each collimator to an angle less than 360 degrees.   31. The method of claim 30, wherein detecting photons generated in response to the emitted radiation comprises rotating each detector to an angle less than 360 degrees. Administering a capsule to a subject, wherein the capsule is configured to be swallowed by the subject;
Emitting radiation from the capsule while the capsule is in the subject's gastrointestinal tract;
Detecting a first signal and a second signal in the gastrointestinal tract of the subject in response to the emitted radiation;
Processing the first signal to generate a first image of the gastrointestinal tract in a region where the first signal is detected;
Processing the second signal to generate a second image of the gastrointestinal tract in a region where the second signal is detected;
Detecting the movement of the capsule by comparing the first image and the second image;
A method comprising: Emitting beta radiation from within the subject's gastrointestinal tract;
Detecting photons generated in response to the emitted beta radiation;
Deriving an indication of tissue density near the radiation site of the beta radiation by analyzing data relating to the detected photons;
A method comprising:   38. The method of claim 37, further comprising distinguishing a) tubular and villous polyps from b) neoplastic polyps by quantifying the tissue density. Detecting electrons generated in response to the emitted beta radiation;
Deriving the tissue density reading comprises deriving the tissue density reading near the radiation site by analyzing data regarding the detected electrons and the detected photons. Item 38. The method according to Item 37. Emitting beta radiation from within the subject's gastrointestinal tract;
Detecting electrons generated in response to the emitted beta radiation;
Deriving an indication of tissue density near the radiation site of the beta radiation by analyzing data relating to the detected electrons;
A method comprising:   41. The method of claim 40, further comprising distinguishing between a) tubular and villi polyps and b) neoplastic polyps by quantifying the tissue density. Emitting radiation from within the subject's gastrointestinal tract;
Detecting electrons generated in response to the emitted radiation;
Detecting photons generated in response to the emitted radiation;
Generating useful information for identifying clinical characteristics of the gastrointestinal tract of the subject by analyzing data relating to the detected electrons and the detected photons;
A method comprising: Emitting radiation from within the subject's gastrointestinal tract;
Detecting Compton backscattered photons generated in response to the emitted radiation;
Distinguish between a) tubular and villous polyps and b) neoplastic polyps by analyzing data on the detected Compton backscattered photons to derive an indication of tissue density near the radiation emission site And steps to
A method comprising:   44. The method of claim 43, wherein emitting the radiation comprises emitting one or more radioactive particles selected from the group consisting of x-ray photons, gamma photons, and beta electrons. Emitting radiation from within the subject's gastrointestinal tract;
Detecting Compton backscattered photons and XRF photons generated in response to the emitted radiation;
By analyzing data on the detected Compton backscattered photons and XRF photons to derive an indication of tissue density near the radiation emission site, a) tubular and villous polyps, and b) neoplastic A step of distinguishing from a polyp;
A method comprising:   46. The method of claim 45, wherein emitting the radiation comprises emitting one or more radioactive particles selected from the group consisting of x-ray photons, gamma photons, and beta electrons. Emitting radiation from within the subject's gastrointestinal tract;
Detecting electrons generated in response to the emitted radiation;
Distinguishing between a) tubular and villous polyps and b) neoplastic polyps by analyzing data on the detected electrons and deriving an indication of tissue density near the radiation site of the radiation; ,
A method comprising:   48. The method of claim 47, wherein emitting the radiation comprises emitting one or more radioactive particles selected from the group consisting of x-ray photons, gamma photons, and beta electrons. Administering a capsule to a subject, the capsule having a radiation source covered by a shield;
Exposing the radiation source by rotating the shield at a rotational speed that exceeds a threshold while the capsule is in the gastrointestinal tract of the subject;
A method comprising: Administering a capsule to a subject, wherein the capsule is configured to be swallowed by the subject to travel through the subject's gastrointestinal tract, the capsule having a first antenna and a second antenna; Steps,
Radiating a first RF pulse and a second RF pulse from the first antenna while the capsule is in the gastrointestinal tract;
Detecting the RF pulse by the second antenna;
Recognizing movement of the capsule through the gastrointestinal tract in response to changes in the detected first and second RF pulses;
A method comprising: Administering a capsule to a subject, wherein the capsule is configured to be swallowed by the subject to travel through the subject's gastrointestinal tract, the capsule having a first antenna and a second antenna; Steps,
Generating an electric field around the capsule at a first time and a second time while the capsule is in the gastrointestinal tract;
Detecting the characteristics of the electric field at the first time and the second time;
Recognizing movement of the capsule through the gastrointestinal tract in response to a change in the detected property;
A method comprising: Administering a capsule to a subject, the capsule configured to be swallowed by the subject to travel through the subject's gastrointestinal tract;
Electronically determining that the capsule has been expelled from the subject's anus by detecting the placement of the capsule;
A method comprising: Obtaining data about the gastrointestinal tract while the capsule passes through the gastrointestinal tract;
In response to detecting that the capsule has been expelled from the subject's anus, downloading the acquired data from the capsule;
53. The method of claim 52, further comprising: Emitting radiation from within the gastrointestinal tract of a subject, wherein the radiation is selected from the group consisting of x-ray radiation, gamma radiation, and beta radiation;
Detecting photons generated in response to the emitted radiation;
Distinguishing between polyps with stalks and polyps without stalks in the gastrointestinal tract of the subject by analyzing data on the detected photons;
A method comprising: Administering a contrast agent to the subject;
Administering a capsule to the subject, the capsule configured to be swallowed by the subject to advance through the subject's large intestine;
Radiating radiation from the capsule through the contrast agent in the large intestine of the subject;
Detecting a photon bundle of Compton backscattered photons and XRF photons generated in response to radiation emitted at a plurality of dense points along the large intestine;
The distance between the capsule and the colon wall is analyzed by analyzing the detected Compton and XRF photon flux and inferring the low degree of concentration change of the contrast agent at the dense point in the subject's colon. A step of determining
A method comprising:   56. The method of claim 55, wherein determining the distance comprises determining an average contrast agent concentration based on the bundle detected at the dense point.   Detecting the photon flux includes detecting the photon flux at each of the capsules at a plurality of dense points, wherein the dense points are within a single bulge of the colon. 56. The method according to item 55.   The step of detecting the photon flux includes the step of detecting the photon flux when the capsule is at a plurality of dense points, the dense point being within a range of 20 to 40 mm in length of the large intestine. 56. The method of claim 55, wherein:

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